Granules Pharmaceuticals Inc. recalls Gabapentin Tablets, USP, 600 mg, 500-count bottles, Rx only, Manufactured by: Granules India Limited Hyderabad-500 081,…
- Recall date
- July 31, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0634-2024
- FDA classification
- Class II
- Brand / firm
- Granules Pharmaceuticals Inc.
- Sold / distributed
- Nationwide in the USA
Why it was recalled
Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin Tablets
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Gabapentin Tablets, USP, 600 mg, 500-count bottles, Rx only, Manufactured by: Granules India Limited Hyderabad-500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA NDC 70010-227-05
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